Systems, methods and products for diagnostic hearing assessments distributed via the use of a computer network

ABSTRACT

The systems, methods and associated devices performing diagnostic hearing tests which use a computer network to allow interaction between a test administration site and one or a plurality of remote patient sites. The test can be administered by an audiologist or clinician at a site remote from the patient, in a manner, which can allow interaction between the user and the clinician during at least a portion of the administration of the test. The diagnostic hearing tests can be performed such that they meet standardized guidelines such as ANSI requirements or certification standards and can include distortion product emission level measurements or middle ear compliance measurements.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.12/256,096 filed Oct. 22, 2008, which is a continuation of U.S. patentapplication Ser. No. 11/113,560 filed Apr. 25, 2005, which issued on May12, 2009 as U.S. Pat. No. 7,530,957, which is a divisional of U.S.patent application Ser. No. 10/068,016 filed Feb. 5, 2002, which issuedas U.S. Pat. No. 6,916,291 on Jul. 12, 2005, which claims the benefit ofpriority of U.S. Provisional Application Ser. No. 60/266,988, filed Feb.7, 2001, and U.S. Provisional Application Ser. No. 60/295,640, filedJun. 4, 2001, the contents of which are hereby incorporated by referenceas if recited in full herein.

FIELD OF THE INVENTION

The invention relates to hearing evaluation systems used to diagnosehearing impairments.

BACKGROUND OF THE INVENTION

It is estimated that approximately 28 million people, including 1.46million children, have a hearing deficiency. Early identification ofhearing loss and appropriate intervention can be critical to preventingor ameliorating further hearing loss or language delay or disorder.Indeed, early identification can be particularly important in childrenwho are, typically, more receptive to rehabilitation.

Conventional hearing evaluation or assessment tests are performed in aclinical setting with personal interaction between the patient and aclinician. In these settings, the patient is often required to sit in asound isolation booth and to visually signal to the clinician whensounds generated from an audiometer become audible. Unfortunately, thisclinic or office setting structure can be burdensome and time consuming,particularly for those individuals located in remote or rural regionswhere health care options may be limited or in industrial settings wherefrequent or periodical screenings may be beneficial.

One presently operating website attempts to reach a broader audience byproviding a hearing screening procedure over the Internet. The screeningis available at the Universal Resource Locator (URL)“www.handtronix.com.” This website provides a rough hearing screeningwhich purports to indicate, as a result of the procedure, whether theuser should obtain a diagnostic hearing test (apparently based onwhether the user fails to discern one or more of the three or four tonesprovided during the test at particular volumes). For example, a sound ata frequency of about 1000Hz may be generated from a personal computer,which is output to the user by the speakers at a certain volume. Thesound frequency may then change to one of three other selectedfrequencies (such as 500Hz, 2000Hz, and 4000Hz). The user can adjust thespeaker volume until they can audibly detect the sound at thatfrequency. The results of such a screening are an indication of whetherthe user should seek a full hearing diagnostic evaluation.Unfortunately, this screening is not a diagnostic hearing test and doesnot meet ANSI guidelines.

In addition, recently, telemedicine has become a viable option forcertain medical procedures. PCT/US98/13681 proposes an automated processfor test tracking analysis and reporting of various diseases and tests.This document briefly notes that the automated system may be useful foradministering non-invasive tests such as hearing tests in the homewithout the physical presence of a physician or audiologist. For thesetests, this reference proposes a test kit which can be obtained from aretailer or organization which can include an electronic auditory(hearing) test which can be transmitted by an auditory transmitter suchas telephone, modem, cable, computer network, television, radio, etc. Asdescribed, the patient inputs test answers into an inputting device,which can be similar to the auditory transmitter, which then directs thedata into a data processing system which analyzes the data. The analysiscan then generate an electronic diagnosis and forward the recommendationor diagnosis to the patient or to a physician or audiologist.Unfortunately, this proposed system automatically performs the test anddoes not employ an audiologist, clinician, or physician, duringadministration of the test. Further, this system does not describe thetest itself, nor how to generate a reliable remotely administered test,which meets standardized ANSI based diagnostic hearing testrequirements.

SUMMARY OF THE INVENTION

Embodiments of the present invention provide systems, methods andassociated devices and computer program products for performingdiagnostic hearing tests which use a computer network to allowinteraction between a test administration site and one or more remotepatient sites. The test can be administered by an audiologist orclinician at a site remote from the patient, in a manner which can allowinteraction between the user and the clinician during at least a portionof the administration of the test. The diagnostic hearing tests can beperformed such that they meet standardized guidelines such as ANSIrequirements or regulatory or certification standards.

The computer network can be a local area network, a wide area network,an intranet (computers connected within a particular organization,company, coalition, or group) or can be the Internet (such as a globalcomputer network, e.g., the world wide web). The hearing test can beperformed such that the hearing tones (frequency and decibel level) aregenerated locally to the patient in response to commands selecting thedesired tone/level which are transmitted from the expert or testadministration site. In addition, the patient's response to each of thehearing tones (output locally) can be transmitted to the remoteadministration site where it can be considered and evaluated. Thus, theclinician can adjust the testing parameters based on the patient'sresponse during the testing procedure, In so doing, the testadministrator can, inter alia, (a) select or adjust the tone transmittedto the patient; (b) repeat one or more of the tones or frequencies;and/or (c) render a diagnostic evaluation.

Furthermore, in particular embodiments of the present invention, thetest sequence and auditory hearing assessment tones may be controlledfrom the remote administration site and the tones generated locally sothat they are output to the patient in a controlled calibrated manner.Embodiments of the present invention may also allow the testadministrator (typically an audiologist) to adjust the test sequence ortone based on the patient's indicated response. Patient input orresponses may also be accepted during the test and the associated datatransmitted back to the administration site.

In certain embodiments, a portable, relatively inexpensive device whichcan operate independent of a personal computer may be provided. In otherembodiments, a device which is configured to operate with a personalcomputer or other data processing system may be provided. Still otherembodiments may allow the test to be generated by specialized softwareexecuting on a general-purpose data processing system. Thus, embodimentsof the present invention may be configured to run locally utilizing acomputer or other general-purpose data processing system in conjunctionwith a sound-generating device, or can be self-contained withoutrequiring the use of a local general-purpose data processing system. Inany event, embodiments of the present invention may also provide formanagement of the remote test by one or more computers at the testadministration or expert site.

Embodiments of the present invention may also include patient-enddevices which are configured to provide, in a calibrated or controlledmanner, hearing assessment signals (speech and non-speech signals) in aplurality of different frequencies (such as 5-10 or more frequencies).In some embodiments, at least 8 different frequencies are evaluatedduring the test, with frequencies ranging between about 20-20,000 Hz,and more typically between about 125-12,000 Hz. The frequency of thetone may also be output to the user/patient with known intensity levelswhich may range from about 0 to about 120 dB (sound pressure level),depending on the test frequency. The hearing test, provided by thecomputer networked system, may be configured to generate tonepresentations which meet ANSI standards, thereby providing, in someembodiments, a web-based testing protocol which meets recognized hearingdiagnostic standards.

In some embodiments, a determination of whether environmental noiselevel meets a predetermined criteria at the patient or local site mayalso be made. For example, a local microphone or other sound detectingdevice may be used to detect the ambient noise level, either before orduring the test, so that undue noise may be identified and the testrestarted or delayed until a satisfactory environment is in place at thepatient site. In some embodiments, this information can ascertain whichtype of headset or output device should be used by the patient at thelocal site.

Particular embodiments of the present invention may include specializedcomputer program signal processing and control algorithms and a local(patient-end) device configured to deliver the hearing assessmentsignals to the patient at the local computer via instructions providedover the computer network or web. The local device includes a transducerto transmit the test signals to the user. For example, the transducercan be a bone conduction oscillator, insert earphones or conventionalsupraaural earphones. Thus, the transducer can be held in a headset,earphones or other speaker output devices (such as hands-free devicesincluding ITE (in-the-ear), BTE (behind-the-ear), and OTE (over-the-ear)devices) such that the hearing assessment signals travel directly intothe ear canal(s) of the patient.

Alternatively, it is anticipated that the local transducer device can bedesktop or handheld speakers operably associated with the local dataprocessing system such that the hearing assessment signals travelthrough the air from a location away from the patient into the ear(s) ofthe patient (although such an output device may also indicate a need fora more controlled test environment to limit interference from undueenvironmental noise). This embodiment may also need to calibrate orcontrol the output of the speakers (or apply a correction to thesignals) to reliably calibrate the output signals across multiple typesof general-purpose data processing systems. This embodiment may alsoneed a more controlled testing environment, such as a sound-insulatedbooth.

In certain embodiments, in response to the hearing assessment signalsassociated with the web-based diagnostic hearing test, the patientinteractively responds to the hearing assessment signals during thehearing test to identify when a hearing assessment signal becomesaudible (such as by pressing a switch or button, clicking on the mouse,depressing a key on a keyboard, selecting an active region of a display,or speaking into a speech-recognition based microphone input system).

Alternatively, or in addition thereto, a biotelemetry mode maybe used,wherein a local device measures middle ear pressure, compliancecharacteristics, changes and/or distortion product emission levels.These biotelemetry measures can be obtained with tympanometry as well asthe measurement of otoacoustic emissions associated with cochlear haircell responses in the ear (such as distortion product emission,transient and/or spontaneous). In operation, in some embodiments, thelocal device can be locally activated upon commands transmitted from aremote site such that the local device obtains the measurement withoutrequiring patient interaction (the latter may then be used, for example,in young children and infants to diagnose abnormalities and/or hearingimpairments), the diagnostic information can then be relayed through thecomputer network to the remote site during the test. In someembodiments, the information can be provided to the remote site andevaluated in a substantially “real time” manner.

In particular embodiments, the diagnostic test is simulcast (preferablyas a two-way video conference) between an audiologist or therapist atthe remote end and the patient at the local end. In other embodiments, aone-way video image (from the patient to the clinician at the testadministration site) can be used. The audiovisual (or visual alone)communication can allow dynamic real-time communication to and from thepatient and a physician or therapist located at the remote site duringthe diagnostic test. Such a simulcast or visual communication may occurwithin or outside the computer network.

In certain embodiments of the present invention, the hearing signals maybe controlled so that each test signal is within about 1% of theindicated value and so that the harmonic distortion meets predetermined(typically ANSI) values to provide a reliable standardized full hearingrange diagnostic evaluation.

In further embodiments of the present invention, hearing assessmentsignals are delivered at multiple frequencies across a wide frequencyband and the signal intensity level is also controlled. Such control maybe independent of any variable volume control action by the patient.Preferably, the signal intensity of the diagnostic hearing tests iscontrolled by the clinician or expert at the administration site and thecommand therefrom is relayed over a web-based system to a local devicewhich includes a sound generator. In turn, the patient can respond tothe test signal (by clicking or inputting to a keyboard, activating aswitch, touching a screen or speaking into a microphone which mayinclude voice recognition software) so that the remotely locatedclinician (at a data processing system remote from the user) is able todetermine when the tones or signals become audible to the patient.

One embodiment of the present invention is a method for performing ahearing evaluation test over a computer network. The method includes thesteps of: (a) administering a hearing evaluation test to a patient usinga computer network, the hearing evaluation test comprising a pluralityof hearing assessment signals at selected frequencies and hearinglevels; (b) transmitting commands from a test administration site to alocal patient testing site during the administering step; (c) generatingthe hearing assessment signals at the local patient site in response tothe transmitting step; and (d) interactively relaying informationbetween the patient located at the local site and a clinician located atthe test administration site during the administering step so that theclinician can evaluate the patient's response to the hearing assessmentsignals, the test administration site being remote from the local site.

The method can be performed such that the hearing evaluation testassessment signals are sufficient in number and variation of frequencyand sound intensity to allow the clinician to perform a diagnostichearing evaluation.

Similarly, another embodiment of the present invention is a method fordelivering a diagnostic hearing test over a global computer network froma test administration site to a patient site, comprising the steps of:(a) generating, at a patient site, a plurality of hearing assessmentsignals at frequencies in the range of about 20-20,000 Hz; (b)transmitting, to the patient, a plurality of hearing assessment signalsfrom the generating step, the plurality of hearing assessment signalsbeing sufficient in number and variation of frequency and sound levelintensity to provide enough information to the test administrationcontrol site to allow a diagnostic hearing evaluation to be performed bya clinician thereat according to predetermined standards; (c)controlling the output of the hearing assessment signals which arerelayed to the patient during the transmitting step at a local site froma test administration site which is remote from the patient site,wherein said controlling step is carried out such that a clinician atthe test administration site determines which hearing assessment signalsof the generating step are relayed locally to the patient, (d).accepting patient input indicating when each of the plurality of hearingassessment signals from the transmitting step becomes audible theretoduring the transmitting step; and (e) diagnosing the hearing ability ofthe patient at the test administration site.

Yet another embodiment of the present invention is a method ofcontrolling a hearing test, which includes the steps of: (a) serving webpages from a web server associated with a hearing test device to a webclient which indicate a status of the hearing test; (b) receivingrequests from the web client which provide parameters for performing thehearing test; and (c) controlling operation of the test device based onthe parameters of the received request from the web client so as toprovide control of the hearing test. The hearing test can be adiagnostic hearing test and/or a biotelemetry measurement of the ear.

Another embodiment of the present invention is a hearing evaluationdevice, The device includes a web server, a diagnostic test deviceoperably associated with the web server and configured so as to becontrolled by the web server. The web server is further configured toserve web pages to a web client which indicate a status of a diagnostichearing test, receive requests from the web client which provideparameters for performing the diagnostic hearing test, and controloperation of the diagnostic test device based on the parameters of thereceived request from the web client.

An additional embodiment is directed to a hearing evaluation device forgenerating hearing assessment signals at a local patient site,comprising: (a) a processor configured to communicate over a computernetwork; (b) a tone generator operably associated with the processor,wherein, in operation, said tone generator is configured to generatetones at a plurality of selected frequencies in the frequency range ofbetween about 20-20,000 Hz; (c) an output device operably associatedwith the tone generator, wherein, in operation, the output deviceadapted to deliver the tones of the hearing assessment signals to apatient undergoing a hearing evaluation; and (d) an input deviceoperably associated with the processor. The input device is configuredto indicate a patient's response to each of the tones of the hearingassessment signals, and the hearing evaluation device is configured toreceive commands from a remote site through the processor computernetwork to select and adjust the tones generated by the tone generator.

Other embodiments of the present invention are directed to methods forperforming a hearing evaluation test over a computer network, comprisingthe steps of (a) obtaining at least one of a tympanometric measurementof middle ear pressure and compliance or the measurement of evokedotoacoustic emissions of a patient using a computer network; (b)transmitting commands from a test administration site to a local patienttesting site during (at least a portion of) the obtaining step; (c)generating the hearing assessment signals at the local patient site inresponse to the transmitting step; and (d) relaying data between thelocal site to a clinician located at the test administration site duringat least a portion of the obtaining step so that the clinician canevaluate the patient's response to the hearing assessment signals, thetest administration site being remote from the local site.

Still other embodiments are directed to methods of controlling anelectrophysiological test involving one or more of evaluatingotoacoustic emissions and tympanometry, the method comprising the stepsof: (a) serving web pages from a web server associated with anotoacoustic auditory evaluation test device configured to measureotoacoustic emissions including at least one of middle ear complianceand cochlear hair cell responses, to a web client which indicates astatus of the otoacoustic evaluation test; (b) receiving requests fromthe web client which provide parameters for performing the otoacousticevaluation test; and (c) controlling at least a portion of the operationof the test based on the parameters of the received request from the webclient.

As will be appreciated by those of skill in the art in light of theabove discussion, the present invention may be embodied as methods,systems and/or computer program products.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a block diagram of a network-computing environment which mayprovide communications between a test administration site and variouspatient test sites according to embodiments of the present invention.

FIG. 2A is a block diagram of a network-computing environment having atest administration site and a local device used by the patientaccording to embodiments of the invention.

FIG. 2B is a block diagram of a network computer environment having atest administration site and a local device configured to communicatewith a local general-purpose data processing system according toembodiments of the present invention.

FIG. 3 is a block diagram of the local or patient end portion of asystem according to one embodiment of the present invention.

FIG. 4 is a block diagram of a portable device configured to locallygenerate and output the test signals in response to a remote command(s)from a test administration site according to embodiments of the presentinvention.

FIG. 5 is a block diagram of a portable device configured to operateindependently of a local computer and to output test signals in responseto a remote command(s) from a test administration site according toembodiments of the present invention.

FIG. 6 is a block diagram of a portable, device configured tocommunicate with a local computer and output test signals in response toa remote command(s) from a test administration site according toembodiments of the present invention.

FIG. 7 is an exemplary screen printout of a web page at the testadministration site which illustrates some of the selections the testadministration site can make during the test according to one embodimentof the present invention.

FIG. 8 is a flowchart of operations for performing a hearing evaluationaccording to embodiments of the present invention.

FIG. 9 is flowchart of operations for a hearing evaluation according toembodiments of the present invention.

FIG. 10 is a flowchart of operations of a hearing evaluation schedulingmethod according to embodiments of the present invention.

FIG. 11 is a schematic of a biotelemetry measurement system used toevaluate otoacoustic emissions and/or middle ear pressure and compliancecharacteristics according to embodiments of the present invention.

FIG. 12 is a simulated representation of a web page displayingtime-dependent measurement data and test parameter selections accordingto embodiments of the present invention.

FIG. 13 is a graph of a sample tympanogram for compliance versuspressure which may be presented on a web page or expert computeraccording to embodiments of the present invention.

FIGS. 14A-14C illustrate examples of data (stimulus and responseparameters) of an electrophysiological auditory evaluation, which may bepresented to the expert for measurement or, analysis of distortionproduct or transient evoked otoacoustic emissions (TEOAE) according toembodiments of the present invention.

FIG. 15 illustrates examples of data that can be generated at the webpage or expert site for a distortion product otoacoustic emissionanalysis according to embodiments of the present invention.

FIG. 16 is a block diagram illustrating of a networked test systemaccording to further embodiments of the present invention.

FIG. 17 is a flowchart illustrating operations of a networked testsystem according to further embodiments of the present invention.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

The present invention will now be described more fully hereinafter withreference to the accompanying figures, in which preferred embodiments ofthe invention are shown. This invention may, however, be embodied inmany different forms and should not be construed as limited to theembodiments set forth herein. Like numbers refer to like elementsthroughout. In the figures, layers, regions, or components may beexaggerated for clarity.

As will be appreciated by one of skill in the art, the present inventionmay be embodied as a method, data processing system, or computer programproduct. Accordingly, the present invention may take the form of anentirely hardware embodiment, an entirely software embodiment or anembodiment combining software and hardware aspects all generallyreferred to herein as a “circuit.” Furthermore, the present inventionmay take the form of a computer program product on a computer-usablestorage medium having computer-usable program code means embodied in themedium. Any suitable computer readable medium may be utilized includinghard disks, CD-ROMs, optical storage devices, a transmission media suchas those supporting the Internet or an intranet, or magnetic storagedevices.

Computer program code for carrying out operations of the presentinvention may be written in an object oriented programming language suchas Java®, Smalltalk or C++. However, the computer program code forcarrying out operations of the present invention may also be written inconventional procedural programming languages, such as the “C”programming language. The program code may execute entirely on theuser's computer, partly on the user's computer, as a stand-alonesoftware package, partly on the user's computer and partly on a remotecomputer or entirely on the remote computer. In the latter scenario, theremote computer may be connected to the user's computer through a localarea network (LAN) or a wide area network (WAN), or the connection maybe made to an external computer (for example, through the Internet usingan Internet Service Provider).

The present invention is described below with reference to flowchartillustrations and/or block diagrams of methods, apparatus (systems) andcomputer program products according to embodiments of the invention. Itwill be understood that each block of the flowchart illustrations and/orblock diagrams, and combinations of blocks in the flowchartillustrations and/or block diagrams, can be implemented by computerprogram instructions. These computer program instructions may beprovided to a processor of a general purpose computer, special purposecomputer, or other programmable data processing apparatus to produce amachine, such that the instructions, which execute via the processor ofthe computer or other programmable data processing apparatus, createmeans for implementing the functions specified in the flowchart and/orblock diagram block or blocks.

These computer program instructions may also be stored in acomputer-readable memory that can direct a computer or otherprogrammable data processing apparatus to function in a particularmanner, such that the instructions stored in the computer-readablememory produce an article of manufacture including instruction meanswhich implement the function specified in the flowchart and/or blockdiagram block or blocks.

The computer program instructions may also be loaded onto a computer orother programmable data processing apparatus to cause a series ofoperational steps to be performed on the computer or other programmableapparatus to produce a computer implemented process such that theinstructions which execute on the computer or other programmableapparatus provide steps for implementing the functions specified in theflowchart and/or block diagram block or blocks.

As noted above, the present invention provides systems, methods andassociated devices for performing interactive diagnostic hearing testswhich use a computer network to allow interaction between a testadministration site and one or a plurality of remote (“local”) patientsites. The term “patient” refers to the individual(s) being tested andcan include the user, subject, or client at the local site. As shown inFIG. 1, the test administration site 10 can be a medical center oruniversity or other desired location from which one or more cliniciansor audiologists can administer the test. As is also shown, the test isrelayed from the test administration site 10 to a desired patient orlocal site 20 through the use of a computer network 15. The local site20 can, for example, be a factory or industrial office 20 a, a medicalrelated facility 20 c, such as a hospital, general practice clinic, orpediatrician's office, and a primary residence or home 20 b. Thecomputer network 15 can be a local area network, a wide area network ora direct connection and may include an intranet (computers connectedwithin a particular organization, company, coalition, or group), anextranet, a Virtual Private Network (VPN), the Internet, including theWorld Wide Web or other such mechanism for allowing a plurality of dataprocessing systems to communicate.

In operation, the test is administered by a clinician or audiologist atthe test administration site 10, remote from the patient site 20, in amanner which can allow interaction (typically one or more of anon-verbal, verbal, and/or visual communication interaction either oneor two way) between the user and the clinician during at least a portionof the administration of the test. The diagnostic hearing tests can beperformed such that they meet or comply with standardized guidelinessuch as the American National Standards institute (“ANSI”) requirementsor other agency or regulatory standards, as desired for the particulartesting authority in a particular jurisdiction.

In certain embodiments, multiple tests can be carried out concurrentlyby the test administration site communicating with multiple particularuse/local patient sites utilizing, for example, different networkaddresses for the test administration site, the local patient sites orboth. In some embodiments, the network address of the particular testsite/device, as well as the date and time of the test, can be used toidentify or correlate the test results to a patient, and allows the useof a patient specific identifier to be tracked therewith.

As described above, the system can be configured to allow the clinicianat the test administration site 10 to control the test sequence andauditory hearing assessment tones from the remote administration site.Thus, the hearing test can be performed such that the hearing tones(frequency and decibel level) are generated and output locally at thepatient site 20 in response to commands selecting the desired tone/levelwhich are transmitted from the expert or test administration site to thelocal site via the computer network. In turn, the local system 20 s,based on the received or relayed commands, generates the tones andcontrols the levels output to the user/patient locally so that they areoutput to the patient in a controlled calibrated manner. In certainembodiments, the system is also configured to accept the patient's inputor response during the test and transmit the associated data back to theadministration site where it can be considered and evaluated. The systemcan also allow the test administrator (typically an audiologist) toadjust the test sequence or tone based on the patient's indicatedresponse during the testing protocol. Thus, the clinician can adjust thetesting parameters or protocol based on the patient's response duringthe testing procedure. In so doing, the test administrator can, interalia: (a) select or adjust the tone transmitted to the patient, (b)repeat one or more of the tones or frequencies, and/or (c) render adiagnostic evaluation.

In particular embodiments of the present invention, the test devices atthe local sites 20 a, 20 b and 20 c operate as servers and the dataprocessing systems at the test administration site 10 operate asclients. In particular, the test devices may be web servers and theclients at the test administration site 10 may be web browsers.Accordingly, conventional client-server techniques may be modified asdescribed below to provide remote control of the test devices by aclient remote from the test devices. Such a web server/web browserapproach may allow for utilization of existing computer networkinfrastructure, such as the Internet, the World Wide Web, intranets andextranets to provide for remote control of test devices withoutrequiring a dedicated communication infrastructure. Furthermore, giventhe ubiquitous nature of the Internet, test devices may readily be movedfrom site to site. Additionally, additional security functionality mayalso be provided. For example, incorporation of a communication protocolstack at the client and the server supporting Secure Socket Layer (SSL)communications or Virtual Private Network (VPN) technology such asInternet Protocol Security Architecture (IPSec) may provide for securecommunications between the patient sites 20 a, 20 b and 20 c and thetest administration site 10 to thereby assure a patient's privacy.

In certain embodiments, as illustrated in FIG. 2A the local system 20 sis configured as a portable relatively inexpensive self-contained device50, which can operate independent of a personal computer and isconfigured to interface with a computer network 15. In otherembodiments, as shown in FIG. 2B, the local system 20 s can include adevice 50′ which is configured to operate with a personal computer 75 orother general purpose data processing system. Still other embodimentsmay allow the test to be generated by specialized software and ageneral-purpose data processing system such as a personal computer.Thus, the system can be configured to run locally off of a computer witha sound-generating device, or can be self-contained without requiringthe use of a local computer. In any event, the system can be managed byone or more computers 175 at the test administration or expert site 10.

The system can include patient-end devices 50, 50′ which are configuredto provide, in a calibrated or controlled manner, hearing assessmentsignals (speech and non-speech signals) in an plurality of differentfrequencies (such as 5-10 or more frequencies). In some embodiments, atleast 8 different frequencies are evaluated during the test, withfrequencies ranging between about 20-20,000Hz, and more typicallybetween 125-12,000 Hz. The frequency of the tone will also be output tothe user/patient with known intensity levels ranging from about 0 toabout 120 dB (sound pressure level), depending on the test frequency.The hearing test, provided by the computer networked system, is able togenerate tone presentations which meet ANSI standards, therebyproviding, in some embodiments, a web-based testing protocol which meetsrecognized standardized hearing diagnostic standards.

Referring now to FIG. 3, one embodiment of a local device 50 isillustrated. As shown, the device 50 includes a tone generator 55, anoutput device 60, an input device 72, and a data processing system 70.The output device 60 can be a transducer such as a bone conductionoscillators or vibrators, insert earphones (i.e., over-the-ear (“OTE”),in-the-ear (“ITE”), behind-the-ear (“BTE”)), or conventional supra-auralearphones. In some embodiments, it is anticipated that speakers may alsobe acceptable output devices.

The data processing system 70 is configured to provide the control andcommunication interface between the local device 50 and the remote testadministration site 10. The data processing system 70 may be any dataprocessing system capable of carrying out the operations describedherein for controlling and providing communications with a computernetwork. Thus, the data processing system may be a general purpose dataprocessing system, such as a personal computer, a specialized dataprocessing system such as a digital signal processor or embeddedmicroprocessor, a network appliance, such as micro web servers or evenpervasive computing devices such as personal digital assistants,smartphones or the like.

The data processing system 70 can receive commands from the clinician atthe test administration site over the communications link to thecomputer network 15 to command the tone generator 55 and can alsoreceive responses from the patient which it then can transmit over thecommunication link to the computer network 15 to the clinician. Thecommunication link to the computer network 15 is illustrative of varioussuitable communications mechanisms that allow the local device 50 tocommunicate with the test administration site over a computer network.Such a communications link may be provided, for example, by a networkinterface of the data processing system. Typical network interfaces mayinclude Ethernet, Token Ring or other such direct connections to acomputer network provided, typically, by network interface card (NICs)or may be provided by, for example, a modem, including cable modems,Digital Subscriber Loop (DSL) modems, including ADSL. an sDSL modems,wireless modems or conventional telephone modems which providescommunications to a computer network. The communications interface and amicro web server embodiment will be discussed further below.

The tone generator 55 is configured to generate the desired frequencytone at the desired level and transmit the tones to the output device60. The tone presentation of the hearing signal generated by the tonegenerator 55 may be “continuously on” or manipulated to present a “pulsetone.” One example of suitable testing protocols is shown in Table 1.

TABLE 1 Frequency and maximum hearing levels for device Hearing LevelsFrequency (dB HL) (Hz) Air Bone 125 70 250 90 45 500 120 60 1000 120 702000 120 70 3000 120 70 4000 120 60 6000 110 50 8000 100 12000 90The tone presentation may be adjusted or determined depending on theconfiguration of the output device in use or the particular testingprotocol desired (different output devices may be used at differentlocal patient sites typically depending on (a) the. patient and (b) thenoise associated with the testing environment). In certain embodiments,the pulse length is presented to the patient such that it does notexceed about 225±35 ms. For air conducted signals, the tone is typicallytransmitted to the user for at least about 20 ms and such that it isequal to or less than about 50 ms. For bone-conducted signals, the riseor onset time shall be no less than 20 ms. When the tone is terminated,the “fall” time is less than about 20 ms. The duration of the tonalplateau can be presented to the patient such that it is equal to orabove about 150 ms.

As shown above in Table 1, the testing protocol can include 10 differentfrequencies ranging from 125 Hz to 12000 Hz. Additional or lesserfrequencies can be used, depending on the applicable test standard,although typically, the test frequencies will be between 20-20,000 Hz.The frequency accuracy for each test signal tone generated can bepresented to the patient such that the signal is within about 1% of theindicated tone frequency.

In certain embodiments, the hearing assessment presentation signals caninclude frequency tones, narrow band noise, broadband noise, recordednoise and speech, as well as live speech. In certain embodiments, thedevice 50, 50′ may also be configured such that the harmonic distortionof the tone frequencies, are able to meet the current ANSI standards, anexample of a current standard ANSI-S3.6 1996 is listed in Table 2. Thus,in certain embodiments, the maximum level of the harmonics of the testtone relative to the level of the fundamental may be presented so as tonot exceed the values given in Table 2 below.

TABLE 2 Maximum permissible harmonic distortion, expressed in percent *Air Conduction Bone Conduction Frequency (Hz) 500- 6000- 500- 1000- 125250 4000 16000 250 750 5000 Hearing level 75 90 110 90 20 50 60 Secondharmonic 2 2 2 2 5 5 5 Third harmonic 2 2 2 2 2 2 Fourth & each .3 .3 .32 2 2 higher harmonic All subharmonics .3 .3 .3 Total harmonic 2.5 2.52.5 2.5 5.5 5.5 5.5 * ANSI-S3.6 1996

In operation,, the desired hearing tone presentation is output to theoutput device 60 and to the patient. In response, the patient canindicate a response to the tone to the input device 72. The input device72 can be a voice activated or speech recognition input microphone, or aphysical input port such as a keypad, button, screen-contact softwareswitch, or physical switch. In certain embodiments, the input device canbe (or include) a video camera 85 which is video linked to the testadministration site 10 so that the clinician can visually monitor thepatient's response during the test. Further, two individually operableinput devices can be employed, one for use when the patient acknowledgesa tone to the right ear and one for when the patient acknowledgeshearing from the left ear. It will be appreciated that, in someembodiments, the input device may be on the output transducer 60 headsetitself as an alternative to the housing body of the device 50.

As is also shown in FIG. 3, the device 50 may, in some embodiments,include a microphone 80 to measure the ambient or environmental noisewithin the testing room or locale, at the patient site 20. Thisembodiment can allow the system to assure that the test complies withappropriate standards, such as ANSI S3.1-1999. This standard specifiesthe maximum permissible noise levels (MPANL) allowed in a room foraudiometric threshold assessment. In certain embodiments, the microphone80 can be configured to measure or detect sound pressure levels or noisein the range of between about 20 Hz to 20 kHz, and may, in someembodiments, detect sound pressure levels at octave intervals 125 to8,000 Hz or up to 12,000 or greater Hz. The microphone 80 may operateprior to initiation of the testing procedure to determine what the noiseor sound level is and if a particular type of output device 55 should beemployed (such as whether supra-aural or insert earphones areappropriate to meet the applicable standard).

Sound Level Measurement of Ambient Noise

TABLE 3 Octave band ears covered maximum permissible ambient noiselevels Octave Band Supra-aural Insert Intervals (Hz) Earphones Earphones125 39.0 67.0 250 25.0 53.0 500 21.0 50.0 1000 26.0 47.0 2000 34.0 49.04000 37.0 50.0 8000 37.0 56.0 Values are in dB re: 20uPa to nearest 0.5dB

In certain embodiments, the microphone 80 may be operable substantiallycontinuously during the entire testing procedure to assess the noiseduring the test and to note either or both at the test administrationsite 10 or the local site 20 the detection of an undesirable ambientsound level or when or if a particular step or sequence should berepeated because of a detection of noise above a certain thresholdlevel. The local system 20 s may also include an audio analyzer 82operably associated with the microphone 80 and the processor 70. Theaudio analyzer 82 can receive sound input from the microphone 80 andanalyze whether the ambient noise level is suitable. The device 50 mayinclude a visual indicator (90, FIG. 5) to note when the sound level isacceptable, unacceptable, or when it is approaching an impermissiblelevel. A general threshold can be used for all types of devices, or canbe monitored for the type of output device 60 used during a particulartest. Examples of visual indicators (typically positioned at one or bothof the local end 20 or test administration 10 sites) include multiplecolor light emitting diodes (LEDs) such as green and red LED's (and mayinclude blue or yellow as well), or text or design/icon active matrixscreen displays which visually affirm or identify the level and thelike. The test administration site 10 can receive (upload) dataregarding the ambient sound level before and/or during the test forevaluation during the procedure.

In other embodiments, a passive biotelemetry reading of thestructure/operation of the ear (i.e., middle ear analysis, cochlea haircell response, and the like) can be obtained. This measurement orreading can be administered in addition to (or separately from) the tonehearing test protocol. The biotelemetry sensor can be incorporated intothe transducer output device 60 or can be an additional component. Inoperation, an operator at the test administration site can activate thelocal biotelemetry sensor in the ear of the subject and the associatedmeasurement can be passively obtained (without requiring the subject toverbally or visually communicate). The measurement can be relayed to thetest administration site 10 via the communication link to the computernetwork 15. As will be discussed below, the processor 70 p associatedwith the patient site 20 can relay the information during the test bygenerating a webpage 70 c and relaying that to a client at the testadministration site.

The biotelemetry methods/systems can acquire multiple data sets andtransmit them through the computer network to allow a remotely locatedclinician to generate a biotelemetry analysis of the auditory system ofthe patient. The multiple data sets can include data corresponding tootoacoustic emissions from either distortion product and/or transientapproaches, middle-ear compliance (achieved from either single ormultiple frequency stimulation and pressure) and/or acoustic reflexresponse. The local biotelemetry sensor may be activated/controlled bythe remote site in a manner that allows for adjustment during themeasurement and/or such that the data is relayed to the remote/testadministration site in substantially “real-time” or at certain points intime during administration of the test. Embodiments of systems andmethods related to web-based acquisition and analysis of transient anddistortion product otoacoustic emissions and middle ear testing will bedescribed further below.

Turning now to FIG. 4, one embodiment of the local device 50 is shown.In this embodiment, the tone generator 55 includes a function generator(e.g. waveform generator) and a tone attenuator and headphones (10 Ohm)that are insertable into the output port 60 p. As is also shown, theinput device 72 is a digital switch. The microphone 80 is operablyassociated with an audio spectrum analyzer 82 which is connected to themicrocontroller 74 through an RS-232 connection. The microphone 80 ispreferably located away from the output device 60 so that it is able topick up ambient noise. The device 50 can also be configured to filterout tones generated from the test itself in the ambient noise evaluationwhere the tones are transmitted through the air (not directly output tothe ear). The audio spectrum analyzer 82 shown includes noise levelindicator lights 90, which are visible to the patient during operation.The device 50 is configured to operate based on a web server 70 wconfiguration and includes the microcontroller 74, an RS-232 bus andport 70 s, a TCP/IP stack 71, and an Ethernet connection 15 c to thecomputer network 15. Examples of suitable components such as the RX-11Tonejack from Conex-Electro Systems (described at URL (www)conex-electro.com) which was modified to include an attenuator, and aVelleman K4300 Audio Spectrum Analyzer Kit available from Radio Shack aspart no. 990-0171.

FIG. 5 illustrates a particular embodiment of the local device 50according to embodiments of the invention where the data processingsystem 70 is a web server. In particular, the data processing system maybe an Internet Appliance, such as a PICOSERVER by Lightner Engineeringlocated in San Diego, Calif. (see also URL (www) picoweb.net) or othersuch web servers, including, but not limited to, those available fromAxis Communications, or PICOWEB, RABBIT, and the like.

As shown, a processor 70 p of the data processing system 70 receivescommands from the clinician at the test administration site 10 andcontrols the function generator 56 and attenuator 57 to output thedesired test sequence and tone to the headphones 60 to the client orpatient. The data processing system 70 also includes a TCP stack 70 tand Ethernet NIC 70 n to provide the communication link 15 c to thecomputer network 15 and to the test administration site 10.

The processor 70 p provides information about the test to the testadministration site 10 as web pages 70 c which may be predefined andstored at the local device 50. Such web pages 70 c may also bedynamically generated to incorporate test specific information. The webpages 70 c may be Hypertext Markup Language (HTML) common gatewayinterface (CGI) web pages which allow for user input by a client, suchas a web browser, of a user at the test administration site 10. The Webpages may also be or include Java scripts, Java applets or the likewhich may execute at the test administration site so as to controloperations of an administration data processing system at the testadministration site 10. As will be appreciated by those of skill in theart, other mechanisms for communicating between a web server and aclient may also be utilized. For example, other markup languages, suchas Wireless Markup Language (WML) or the like, for communicating betweenthe local device 50 and the administration site 10 may be utilized.

When the test sequence and tone are output, the patient indicates when atest tone is audible, such as by depressing the input switch 72. Theactivation from the input switch is relayed back to the processor 70 pvia an internal directional switch 172 which generates and/or selects aweb page 70 c to be served to a client at the test administration site10. In particular embodiments, the client at the test administrationsite is provide with a Java applet which causes the client toperiodically request a web page from the local device 50. When the nextweb page is requested by the client, the processor 70 p provides thegenerated and/or selected web page reflecting the activation of theinput switch.

Similarly, the microphone 80 detects ambient sound and inputs the dataassociated therewith into the audio analyzer 82 which can determine theambient noise level for the test and relay the information via a switch182 to the processor 70 p. The processor 70 p can, in turn, relay theinformation to the test administrator during and/or before the test asdescribed above by generating and/or selecting a web page 70 c andserving that web page to a client at the test administration site 10.

Turning to FIG. 6, in other embodiments, the device 50′ is configured toconnect with a local computer such as a personal computer. The localcomputer 75 can be any suitable type whether a palm, laptop or desktopcomputer and the like. Alternatively, the local computer 75 may bepervasive computing device such as a smartphone or a PDA. Thus, in thisembodiment, the device 50′ includes the tone generator 55 and toneoutput port 60 p. Optionally, in some embodiments, the device 50′ mayalso include the microphone 80 and the audio analyzer 82. The device 50′may be provided as an internal for incorporation into the local computer75 or as an external device. For example, the device 50′ may be providedas a plug-in module, such as a “Springboard” for inclusion in a VisorPDA from Handspring. Alternatively, the device 50′ maybe a PCMCIA cardwhich may be readily plugged into a laptop or other such general-purposecomputer. Furthermore, the device 50′ may be a separate unit whichconnects to, for example, the serial port of a general-purpose computer.

As shown in FIG. 5, the processor 70 p, web pages 70 c, TCP stack 70 tand Enterhnet NIC 70 n can be provided by the local computer 75. In thisembodiment, the display screen and/or keyboard of the local computer 75may be used as the input device 72 (or may be used along with an inputdevice in the device 50′). Similarly, the video link described above maybe provided by the local computer 75. The operational software needed tosupplement the local operating system may be provided as a packagedproduct which is downloadable onto the local computer or may be providedat a URL location to be electronically downloadable therefrom.

FIG. 7 illustrates an example of a web page 100 which may be served tothe test administration site 10 by the local device 50, 50′ to allowcontrol of the local device 50, 50′. As shown, this web page 100 may beprovided from the server of the local device 50, 50′ to a client, suchas a web browser, at the test administration site 10 and includes testcontrol parameters which can be activated and/or adjusted by theclinician during the test. The test parameters shown include a power oncontrol 110, a tone on 120, tone off 130, selectable frequency, andindependently selectable left and right intensity controls 146, 147. Thepower on control 110 can activate the tone generator 55 or functiongenerator 56 at the local site 20 (deselecting this control then powersoff or deactivates the tone generator 55). The tone on and tone offcontrols 120, 130 are typically operably associated with an attenuatorand/or output switch and allows the clinician to control the length (orto initiate at desired intervals and terminate the sound when theresponse is indicated) of the tone signal output to the patient at thelocal site. The select frequency control 145 allows the clinician toadjust the test frequency and order of the testing protocol. The leftand right intensity controls 146, 147 allow the clinician to adjust theintensity in the desired ear for each frequency selected. The data box150 identifies the sound pressure level correction for each frequency.The exemplary screen display shown is for discussion purposes and, it isnoted that, the screen layout, test parameters, and activation and/orcontrol features may vary.

The illustrated controls may be selected by a user at the testadministration site 10 by, for example, clicking on, touching, orpointing to, the particular control in displayed by the web browser.Such a selection may cause an indication of the selection to betransmitted to the web server of the local device 50, 50′. For example,a CGI response would be provided to the web server indicating selectionof the power on 110 pushbutton. The CGI response would be parsed by theweb server of the local device 50, 50′ and the results used to controlthe state of the local device 50, 50′.

Operations of a web server and a web client according to embodiments ofthe present invention will now be described with reference to FIG. 8. Asseen in FIG. 8, the client, e.g., the web browser as the testadministration site 10, requests an initial web page from the web serverof the local device 50, 50′ (block 160). Such a request may take theform of an Hypertext Transfer Protocol (HTTP) request to the IP addressof the web server of the local device 50, 50′. The IP address may bepre-assigned to the local device 50, 50′ or may be dynamically assignedwhen the local device 50, 50′ attaches to the network 15. Thus, the webbrowser may know in advance the IP address of the local device or may benotified of the IP address by a user at the remote site as part of asetup procedure.

When the local device 50, 50′ receives the request for the initial webpage, it sends the initial web page and a Java applet which causes theweb browser to periodically reload its current web page (block 162).Alternatively, “push” technology could be employed by the server to pushdata to the web browser when status is to be updated. The rate at whichthe web page is reloaded may be based on the type of test beingperformed or the web page being displayed. Similarly, the rate may alsobe based on the type of network connection utilized such that for slowerconnection types the refresh rate could be reduced. While the embodimentillustrated in FIG. 8 illustrates providing the Java applet once withthe initial web page, the Java applet could be provided with each webpage and refresh rate could be based on the particular web pageprovided. For example, a setup web page could be refreshed less oftenthen a test status web page (or not at all).

In any event, after the initial web page is provided to the web browser,the web server of the local devices 50, 50′ waits for a subsequentrequest for a web page (block 164). When a request is received, it maybe determined if the request is for a response to a test, such asactivation of a switch or ambient noise level information, which is tobe included in the responsive web page (block 166). If so, then the webpage may be revised to indicate the information (block 168). In anyevent, it may also be determined if the request specifies parameters forthe test (block 170) by, for example, providing a CGI request whichreflects user input to the web browser. If so, the test parameters areset based on the CGI specifications (block 172) and the web pagecorresponding to the URL of the request is returned to the web browser(block 174). If the test is terminated (block 176), then operations mayterminate. Otherwise, the web server waits for the next request from theweb browser (block 164).

FIG. 9 illustrates one embodiment of a method for administering ahearing test. As shown, an “appointment” time is established for thehearing test to be administered (to allow the interchange between theclinician and the patient) (block 200). The electronic communicationlink is established between the test administration site and the localpatient site (block 210). The test commands are transmitted by theclinician to the local site during the testing protocol to generate thedesired tone presentation to the patient (block 220). The patient'sresponse to the test signal(s) is received during the testing protocol(block 230). The response can be a measurement taken from a probe in theear as well as input to indicate when a tone is heard (which input canbe visual, verbal or spoken, or contact such as keypad or switch) or abiotelemetry reading can be obtained automatically. Optionally, aone-way or two-way video link (or audio-video line) may be providedbetween the patient and clinician during the testing protocol (block235). The patient response input can be relayed back to the clinician atthe test administration site (block 240). The clinician receives andconsiders the patient response to establish/adjust the teat protocol ortesting parameters (block 250). A hearing diagnosis can be renderedbased on the information provided by the test (block 260).

In certain embodiments, as shown in FIG. 10, an appointment can beestablished by sending a request for an appointment to the testadministration site (block 300). This can be telephonically establishedor can be established via the use of electronic mail (email) or othersuch communication including a chat session or the like. In someembodiments, a block of time may be pre-established for certain localsites such as hospitals, pediatrician's offices, and the like. Next,patient identification data can be entered into an electronic record(such as name, social security number, date of birth, referring doctor(as needed), and the like) (block 310). Insurance information can alsobe provided as needed (block 320) (such as policy, type, insurancepre-certification approval number, and the like). A template may be sentfrom the test administration site (block 305) to present data fields forthe local site to complete to help build a complete record. Based onthis information, the test administration site can verify whether areferral is needed to get insurance approval for the test based on alist of insurance policies and companies in a database or by contactingsame. If a referral is indicated as needed, and no referral informationhas been entered in electronic record, the local site can be contactedto notify the patient (block 360). Similarly, if pre-certification orapproval is needed from the insurance company which has not beenobtained, the local site can be notified (block 360) and the testadministration site may transmit the request to the insurance company(block 363). Alternatively, a “click” agreement can be entered wherebythe local site/user provides a credit card number and agrees to assumefull payment and bypasses the referral/insurance referral steps (block362). In such embodiments, the local devices 50, 50′ could operate asboth a server and a client such that information could be provided fromthe test administration site to a browser or other client at the localdevice 50, 50′. The system can be configured such that any privateinformation input as described above can be entered in secure/privacyprocedures known to those of skill in the art, such as using a VPN orSSL as described above.

If all is in order, the local site can select the desired date and time(block 330). This can be done in several ways such as by selecting froma list of available time slots and dates provided from the testadministration site. The available slots may be provided with the use ofa calendar format (highlighting dates on which appointments areavailable during a month period). The local site can select byhighlighting or clicking on the desired date and test time. The patientcan be assigned a unique identifier/confirmation number. The testadministration site can then electronically commence the communicationlink at the appointment time at the electronic address provided (block340). This may be provided either by the email address or by the IPaddress or other electronic address identifier associated with thedevice 50, 50′ which will be used for the test. Automatic reminders ofthe test date can be sent at desired intervals such as at 1 week/24hours before the appointment time (block 345). This reminder can be bytelephone or electronic mail.

Turning now to FIG. 11, certain embodiments of the invention aredirected to electrophysiological tests of audiological procedures formeasuring otoacoustic emissions and/or using tympanometry and includessystems, methods, and devices which are configured to stimulate andobtain for evaluation, signals associated with the otoacoustic emissionsand/or responses or acoustics reflexes of a subject via a computernetwork system. As before, the computer network can be a local, regionalor global system such as the worldwide web (i.e., the Internet). As forthe diagnostic hearing evaluation systems, in these embodiments, thesystem includes a patient end or “local” device 450 at a local site 20and an expert end or “remote” device 10 which are operatively connectedvia the computer network 15. The local device 450 can be configured tointeractively respond to commands sent from an expert at the remote site(such as a clinician or audiologist) during a portion, or all, of thetesting procedure.

In operation, the local or patient end device 450 can stimulate one ormore of the subject's ears (independently) via test signals and thendetect one or more responses to provide multiple data sets associatedwith multiple parameters used to evaluate the subject's auditoryresponse. The evaluated auditory responses can include one or more of(1) otoacoustic emissions from either (or both) distortion product ortransient approaches, (2) middle-ear pressure and compliancecharacteristics (typically based on either a single frequency ormulti-frequency stimulation and pressure), and (3) acoustic reflexresponse. Of course, the local device can be configured to provide boththe hearing evaluations discussed above and the electrophysiologicalauditory response evaluation (each test type can be carried out with anintegrated headset or a different headset, preferably employing adisposable single use probe assembly or ear insert device).

In certain embodiments, as shown in FIG. 11, the patient end device 20includes an in-the-ear probe assembly 475 which is configured totransmit a stimulus signal or signals 480 into an ear of the subject andthen sense (passively obtain) the desired emission or response signals481. The detected or sensed response signals 481 are then relayed to thelocal device 450, where signal processing can occur, and then to theexpert site 10 via the network 15 for evaluation. In operation, the testor stimulation signal 480 is output locally via the probe assembly 475to the patient based on the desired test signals and/or parameters(and/or sequence) selected by the clinician at the remote site. Inaddition or alternatively, the parameters, sequence, or timing of thetest may be altered or adjusted by the clinician at the remote siteduring the test. The clinician can, in certain embodiments, receiveresponse data associated with the test stimulation protocol at certainintervals during the testing procedure or semi continuously orcontinuously during the test. The clinician can, as desired or needed,select, adjust, repeat, or test the other ear or otherwise manipulatethe testing protocol during the evaluation depending on the patient'sresponse or the detected ambient noise in the testing environment.

The local device 450 can include an environmental noise evaluationmicrophone 80 (as discussed for the device 50, 50′) which can detectambient noise before, or during, the test so that the remote site candetermine the validity or reliability of the data. In some embodiments,the ambient noise data can allow the potentially corrupt data to bereplaced by a supplemental test before the conclusion of the testingprocedure, where needed. The microphone 80 may be positioned on thelocal device 450 (not shown). Alternatively, the microphone 80 may bepositioned on the probe assembly 475 itself (such as on the portion ofthe probe assembly facing away from the inner ear). As an additionalalternative, the microphone 80 may be positioned on a supplementalhousing spaced apart from the probe assembly or mounted separately tothe subject or otherwise disposed proximate the subject during thetesting procedure (not shown). This may be helpful for infant testingwhere sneezing, coughing, and the like can be detected during thetesting protocol.

As schematically shown by the clock 190 in FIG. 11, the system can beconfigured such that the remote expert site 10 is able to receive dataand/or transmit requests to the local device 450 during the test insubstantially real time or to control the test (or a portion thereof,such as the initiation of the testing sequence, the change from one earto another, or the upload of data). As used herein, the term“substantially real time” means receiving and/or transmitting databetween sites during the test or temporally proximate in time theretoaccounting for system delays in remote transmission between sites whichmay be seconds or minutes in length or longer as a result of routing,traffic, transmission route, and/or system communication link employedwhich can impede the transfer such that slight delays may occur.

The local device 450, as for devices 50, 50′, can be configured as astand alone device (as shown), preferably with signal and dataprocessing capability, and remote communication link 450 c (whether viaone or more of wireless, tower or satellite transmission, cable,telephone, fiber optic, or other communication link) so as to be able totransfer or upload data to (and preferably from as well) the remotelocation. In certain embodiments, the local device 450 is portable andmay be implemented as a pervasive computing device that is configured togenerate the desired test signals and to receive the response signalsand relay the information to the remote site via the communication link450 c. Alternatively, the local device 450 can be configured to beoperably engageable with a local computer or pervasive communicationsdevice (whether stationary or portable such as a laptop, handheld, orother miniaturized device) during the test, which, in turn, may providethe modem or communication link to the network 15 and to the remotesite. The device 450 may be configured to engage with a local computeror portable communications device or pervasive computing device viahardwired electrical connections, or wireless signal transmissionincluding infrared data transmission means.

In certain embodiments, as before, the processing or control systemassociated with the local device 450 can be configured to relay the testdata by use of a web server and web client. The web server and webclient configuration may be such that a webpage is generated at thelocal site and relayed to the expert or test administration site. Thewebpage can be updated a plurality of times during the test to relaydifferent data sets to the clinician during the test. In any event, theremote site computer can be configured to access the status of the localdevice, and to initiate the testing procedure or to upload datadepending on the status determination. Thus, the local device can beconfigured to allow a local operator to power up and depress a “readybutton” when the probe assembly is in position. Alternatively, theremote site can be used td power up the local device and to transmitstatus signal requests until the device is deemed to be in suitableposition in the subject. As noted above, a camera may also be used toallow the remote site to visually note when the local device and patientare ready for the testing procedure.

Referring to FIG. 11, in operation, in certain embodiments, the localdevice 450 is configured to generate stimulation signals correspondingto the testing protocol associated with the desired test (such as middleear compliance or distortion product type evaluations). The stimulationsignals 480 are transmitted from an output source located in the earprobe assembly 475, such as one or more speakers 482 having suitableoperating characteristics in the desired frequency range (such as modelER-2 speakers from Etymotic Research Corporation, believed to have arelatively flat response from about 200 Hz-10 kHz). The probe assembly475 can also include one or more sensors 483 such as transducers and/orone or more miniaturized low noise microphones oriented and configuredto sense signals evoked in the ear of the subject. The sensor 483detects the evoked response signal and relays the signal (typically as adigital signal converted by an A/D converter, as well known to those ofskill in the art) to the local device 450. The local device 450 candirectly relay the detected signals in the form in which they arereceived. Alternatively, the local device 450 (or associated computer orsignal processor) can process the received signals into a desired formatbefore transmitting to the remote site. For example, the data processoror the digital signal processor in the local device 450 can generate atime dependent measurement profile of the response of a particularsegment or portion of the test (i.e., a selected test segment) and thenrelay the profile(s) at selected times during the test, such as after adelay of 5 ms-30 seconds after each test stimulation sequence or segmentor just prior to the initiation of the next testing sequence. The datatransfer can be structured in any desirable format, such as to transferdata sets for each test segment and, where desired, transfer therelevant ambient noise data for the same time period. The data transfercan be performed in serially successive data uploads to update thewebpage a plurality of times during the testing procedure.

In any event, as shown in exemplary method steps in FIG. 8 and as aexemplary webpage in FIG. 12, the webpage 100′ can be updated one ormore times during the testing protocol or testing segment to show thedetected time-dependent response (and may also show or indicate that thenoise threshold is below or above a selected desirable threshold level).The webpage 100′ may also allow the clinician to select the testingstimulation activation via a test activation button 495. The activationbutton can be used to activate the local device to relay the testsignal(s) to the subject for a particular ear (shown as parameter “Z”),to allow the clinician to adjust or select a particular frequency (shownas parameter “X”) or decibel or pressure level (shown as parameter “Y”),or merely to initiate or restart a standardized protocol, testingsequence or segment (a “segment” referring to a subset of the overalltesting procedure).

For embodiments directed to the measurement of middle ear pressure andcompliance characteristics through acoustic imittance, the presentinvention can allow the diagnostician (at the remote site) to passivelyanalyze the characteristics of the middle ear. The system maybeconfigured to present both a probe tone (typically at about 226 Hz) anda change in air pressure to the ear canal undergoing analysis. Themicrophone of the device measures the amount of acoustic energytransmitted through the tympanic membrane. This reading is transmittedfrom the probe assembly 475 at the local site 20 via a web server foranalysis at the remote computer site 10.

FIG. 13 illustrates a “tympanogram” or graph format of a tympanometricmeasurement test that may be electronically generated (or datacorresponding thereto rendered) as a part of a web page or on the expertend computer during tympanometry evaluation of the patient. The verticalaxis (from 10-0) corresponds to the measurement of compliance while thehorizontal or “X” axis corresponds to the measurement of pressure (shownas values of between about −400−+200 daPa).

FIGS. 14A-C illustrates an exemplary web page format (that may begenerated at the expert end of the system) with three different segmentsassociated with measurement of evoked otoacoustic emissions. The uppergraph in FIG. 14A illustrates a temporal waveform of the stimulus whilethe lower graph in FIG. 14A illustrates a spectral waveform of thestimuli (in frequency response, where a substantially flat waveform isdesired). The data at the bottom of FIG. 14A corresponds to the peakstimulus intensity level (in dB SPL), stability (shown as a percentage),and the number of stimulus repetitions (illustrated as 260) over thespan of the OAE measurement.

FIG. 14B is a data segment directed to noise evaluation data. As shown,this segment describes the average noise level in the testingenvironment (average level in dB SPL, the number (“Quiet N”) of thetesting stimuli presented to the ear, the number of testing stimuliwhich were presented when the noise level was lower or higher than adesired noise threshold level (“N”), and the percentage of the testingsignals presented during low noise periods. The noise segment can alsoinclude data corresponding to peak noise at the patient end or linedisruptions/power variation or noise introduced or detected during datatransfer from the local to expert site. Of course, the noise segment canbe combined, altered, or eliminated from the web page, or may be a pulldown page which can be easily accessed as desired (such as when aninordinate number of signals occurred with an undesired noise level).

FIG. 14C illustrates a response segment that provides data in a graphicformat corresponding to the response of the patient. The upper graph inFIG. 14C is a temporal waveform of the TEOAE's measured in the externalear canal (measured in pressure units of Pa) (as shown, there are twoseparate waveforms monitored) over a time span of about 0-20 ms. Thelower graph is representative of the response spectrum (measured in dBover a frequency range of interest). The noise floor (shaded region) canalso be included in this data representation (the noise corresponding tothat concurrently detected during the testing procedure). This segmentcan also include how the TEOAE response may be correlated characterizedas data over frequency ranges of interest (as SNR (signal to noiseratio)) in dB at discrete frequencies of interest (shown as 1 kHz, 2kHz, 3 kHz, 4 kHz, and 5kHz). As known to those of skill in the art, thecorrelation may be a quantified as a correlation in percent(reproducibility) between the two (or more) different waveforms and/oras the ratio or difference between the amplitude of the TEOAE versusnoise within certain frequency bands or regions (shown as octavefrequency bands).

FIG. 15 is a graph of distortion product (DP) amplitude (dB SPL) over astimulus frequency range of interest (shown as f₂ frequency over about a500-10,000 Hz). This type of format can be described as a “Dpgram”.During the evaluation, the number of stimulus, frequencies per octaveand the number of octaves in the test may be manipulated by the expertsite. In the example shown, a diagnostic evaluation using DPOAE's forfour frequencies per octave over a range of about 500-10,000 Hz). Theenclosed region in the graph corresponds to a “normal” range for DPOAEamplitudes in a desired population (such as infant, pediatric,adolescents, adult, or senior populations). The points (shown as shadedcircles) drawn proximate the enclosed region corresponds to the DPOAEamplitude of the patient being tested. The DPgram can include a linecorresponding to an upper limit for noise within the ear canal of acorresponding population segment (in substantially the same testingenvironment). As shown, the upper limit is set at the 95^(th) percentileof an adult population). The results shown in this figure are deemednormal. For more information on otoacoustic tests, see James W. Hall,Handbook of Otoacoustic Emissions, (Singular Publishing 2000); FrederickN. Martin, Introduction to Audiology, A study Guide, (Prentice-Hall,1991), the contents of which are hereby incorporated by reference as ifrecited in full herein.

In a preferred embodiment, the system is configured to allow themeasurement, screening and diagnostic assessment via a computer networkto include the Internet so that the assessment can be performed at theremote (expert site) 10. The systems will transmit testing signals whichcan be in a range of between about 1-8 kHz at selected stimulus levels(such as at selected decibel levels within about a 60 dB range). Thesystem then detects, measures, and records or transmits datacorresponding to same from the local site 20 to the remote site 10, tothereby provide the distortion product emission (DPE) levels in the ear.These measures are associated with cochlear hair cell activity in theinner ear. These measures can be very effective in the diagnosis andscreening of hearing loss categories. In certain embodiments, the systemcan present two primary tones at the ear canal. The cochlea produces aresponse to these stimuli, which is received by a microphone in theprobe assembly. This signal is detected and relayed via the computernetwork (preferably via a web server) to the remote computer foranalysis and possible modification of the test procedure as discussedabove. See U.S. Pat. No. 5,885,225 to Keefe et al. and U.S. Pat. No.5,664,577 to Lonsbury-Martin et al., for a description of testingprotocols, signals, and systems, and/or ear probes, the contents ofwhich are hereby incorporated by reference as if recited in full herein.

FIG. 16 illustrates further embodiments of the present invention thatmay use a conventional audiometer configured to interface with a webserver. As seen in FIG. 16, a client 1600 communicates with a web server1610 over a network and/or networks 1605. The client 1600 may be aconventional web client configured as described herein and may include,for example, a networked computer, such as a desktop computer, a mobilecomputer or the like. The network 1605 may be the Internet, an intranet,a local area network, a wide area network, a wireless network and/or awired network. The web server 1610 may be a general purpose computer, anetwork appliance or the like or any data processing system capable ofcarrying out the operations described herein. In a particular embodimentof the present invention, the web server is based on RabbitCore orRabbit 2000 products provided by Rabbit Semiconductor of Davis, Calif.

The web server 1610 communicates with an audiometer 1620. The web server1610 communicates directly to the audiometer 1620 and/or communicateswith the audiometer 1620 through an interface module 1615. For example,the interface module 1615 may be provided by a microcontroller, such asa PIC16C74 from Microchip Technology, Inc. of Chandler, Ariz. The webserver 1610 may communicate directly with the audiometer 1620, forexample, utilizing the NOAH protocol from the Hearing InstrumentManufacturers Software Association, so as to provide improvedperformance, for example, in instructing the audiometer 1620 to initiatea test or in obtaining status information from the audiometer. The testand/or setup parameters of the audiometer 1620 may be set through theinterface 1615 as well as obtaining test results. The audiometer 1620provides a test signal to a transducer and receives a response from thepatient, for example, by pressing a button.

FIG. 17 illustrates operations according to embodiments of the presentinvention. The operations illustrated in FIG. 17 may be carried out bythe system of FIG. 16. As seen in FIG. 17, the client 1600 pings the webserver 1610 (block 1700). If a response to the ping is not received(block 1705), operations may terminate or the ping of a same IP addressor a different IP address may be performed until a response is received.If a response to the ping is received (block 1705), the client 1600initiates a status request to the web server 1610 (block 1710). The webserver 1610 collects the requested status information, for example, byrequesting information from the audiometer 1620, and returns the statusinformation to the client 1600 (block 1715). The client 1600 displaysthe status information for the operator and determines, for example, byreceiving input from the operator, if any parameters are to be changed(block 1720).

If parameters are to be changed (block 1720), the web server 1610receives the new parameters from the client 1600 (block 1725). The newparameters are passed to the audiometer 1620, either directly from theweb server 1610 or through the interface 1615 (block 1730). The client1600 may initiate a further status request (block 1710) to confirm thatthe parameters have been properly received and operations continue untilno changes in the parameters are needed (block 1720).

When no parameters are to be changed (block 1720), the client 1600instructs the web server 1610 to initiate the stimulation (block 1735).The web server 1610 initiates the stimulation by the audiometer 1620,either directly or through the interface 1615, and collects data on thepatient response (block 1740), either directly or through the interface1615. The response data is provided to the client 1600 (block 1745) fordisplay to the operator. If more tests are to be performed (block 1750),operations may continue from block 1720.

The flowcharts, features and/or block diagrams of FIGS. 1 through 17illustrate the architecture, functionality, and operation of possibleimplementations of systems, methods and computer program products foroperating an auditory test and/or allocating bandwidth according tovarious embodiments of the present invention. In this regard, each blockin the flow charts or block diagrams may represent a module, segment, orportion of code, which comprises one or more executable instructions forimplementing the specified logical act(s). It should also be noted that,in some alternative implementations, the acts noted in the blocks mayoccur out of the order noted in the figures. For example, two blocksshown in succession may, in fact, be executed substantiallyconcurrently, or the blocks may sometimes be executed in the reverseorder, depending upon the functionality involved. Similarly, blocks maybe combined such that a single module, circuit or the like provides thefunctionality of multiple blocks. For example, the interface 1615 ofFIG. 16 could be combined with either the audiometer 1620 or the webserver 1610. Similarly, the web server 1610 and the interface 1615 couldall be combined into the audiometer 1620. Alternatively, if sufficientfunctionality is provided by the interface 1615, the direct connectionfrom the web server 1610 to the audiometer 1620 may be eliminated. Thus,the present invention should not be construed as limited to the specificdivision of functions illustrated in particular embodiments of thepresent invention described herein.

The device 50, 50′, 450, as well as the web server 1610, interface 1615and audiometer 1620, can be configured as a portable unit which canallow a clinician at the patient site to transport the device to varioussites (such as different rooms or hospital beds in the clinicenvironment or assisted living homes, or when visiting homes for longterm or outpatient care). The hearing output device 60 or ear probeassembly 475 may be configured to be a single use disposable device,being initially sterilized for sterile testing conditions. For example,a single use, disposable (cost effective) ITE-or earplug design can beused either for a biotelemetry reading and/or for the tone output. Insome embodiments, the devices may be provided on a “lending basis” andshipped out for use and returned.

Furthermore, while the present invention has been described withreference to a web server “serving” web pages to a client, as will beappreciated by those of skill in the art, alternatively, the web servermay host socket connections to a client or clients and transfer datadirectly over such hosted socket connections. Such a direct transfer ofdata may be advantageous in that the overhead associated transmitting aweb page in, for example, HTML may be avoided. In such a case, programsfor sending and receiving data over a TCP connection may be provided atthe client and the server and the data interpreted and/or displayed byan application and/or applet executing at the client.

Embodiments of the invention will be further described with reference tothe following examples, the subject-matter and/or results of which isnot meant to be limiting to the scope of the invention.

EXAMPLES

A pilot study was performed on 30 adult subjects (one ear per adult) totest the reliability and validity of the web-based system. This studyconsisted of a double-blind protocol. The investigators performed twostandard pure-tone hearing threshold tests. One test was performed witha standard onsite audiometer and another test was performed with acomputer web-based system of assessing hearing thresholds according toembodiments of the present invention. The participants received thesetests “blind” to the examiner, as well as to which equipment was beingused. The participants were placed behind a partition during the use ofthe standard audiometer. The participants were placed in a separate roomduring the use of the web-based hearing assessment. The participantsreceived pure tones of 250, 500, 1000, 2000, 3000, 4000, 6000, and 8000Hz at levels of 0 to 90 dB hearing level. These are standard acousticstimulations during hearing assessment. The participant was asked topush a button when they heard the tone. The procedures tookapproximately 30 minutes.

Preliminary findings indicate strong aggreement between the traditionalaudiometric measuring equipment and the web-based system as illustratedby Table 4 below. The differences found are well within normalvariations.

TABLE 4 Mean auditory thresholds (dB) by system in thirty adult earsFrequency (Hz) 250 500 1000 2000 4000 8000 Control 19.5 22.0 12.0 8.58.0 14.0 Experimental 20.5 21.5 13.0 10.0 8.0 15.0

The foregoing is illustrative of the present invention and is not to beconstrued as limiting thereof. Although a few exemplary embodiments ofthis invention have been described, those skilled in the art willreadily appreciate that many modifications are possible in the exemplaryembodiments without materially departing from the novel teachings andadvantages of this invention. Accordingly, all such modifications areintended to be included within the scope of this invention as defined inthe claims. In the claims, means-plus-function clauses, where used, areintended to cover the structures described herein as performing therecited function and not only structural equivalents but also equivalentstructures. Therefore, it is to be understood that the foregoing isillustrative of the present invention and is not to be construed aslimited to the specific embodiments disclosed, and that modifications tothe disclosed embodiments, as well as other embodiments, are intended tobe included within the scope of the appended claims. The invention isdefined by the following claims, with equivalents of the claims to beincluded therein.

1. A hearing evaluation device, comprising: a portable diagnostichearing test device with a communications interface that is configuredto communicate with a remote computer associated with a clinician viathe Internet, wherein the portable diagnostic hearing test device has anon-board function generator and attenuator, and wherein a clinicianusing the remote computer controls the function generator during adiagnostic hearing test to select test frequencies and sound levels ofsound stimuli transmitted by the portable device to a patient during thehearing test.
 2. The device of claim 1, wherein the portable diagnostichearing test device includes a processor operably associated with thefunction generator and attenuator and further comprises an audioanalyzer in communication with the processor.
 3. The device of claim 1,wherein the portable diagnostic hearing test device is configured toallow substantially real-time interaction between the clinician at theremote site and the patient at a test site using the portable diagnostichearing test device.
 4. The device of claim 1, wherein the portablediagnostic hearing test device is configured to generate sound stimulithat comply with predetermined testing standards.
 5. The device of claim1, further comprising an output device in communication with thefunction generator, wherein the output device comprises a transducer fortransmitting the sound stimuli to the patient, and wherein the portablehearing test device includes a user input device in communication withthe communications interface that allows a user to indicate a responseto clinician-initiated test sound stimuli.
 6. The device of claim 1,wherein the portable diagnostic hearing test comprises a biotelemetrymeasurement system in communication with the communications interface,wherein the portable diagnostic hearing test device is configured toallow the clinician to control the biotelemetry measurement system usingthe remote computer to evaluate otoacoustic emissions and/or middle earpressure and compliance characteristics.
 7. The device of claim 4,wherein test signal tones of the sound stimuli are presented to thepatient such that the signals are within about 1% of an indicated tonefrequency.
 8. The device of claim 1, wherein the portable diagnostichearing test device generates the sound stimuli includes frequencytones, narrow band noise, broadband noise, recorded noise and speech,and live speech.
 9. The device of claim 1, wherein the sound stimuli isconfigured to have harmonic distortion of tone frequencies that meetANSI standards.
 10. A method of providing diagnostic hearing evaluationsusing the internet, comprising: providing a portable hearing test devicehaving an on-board audiometer to a patient; connecting the portablehearing test device at a local patient site to a remote testadministration site using a computer network; allowing a clinician tocontrol a diagnostic hearing evaluation test administered to the patientusing the computer network, wherein the clinician at the remote testadministration site controls hearing assessment signals generated by thehearing test device at the local patient site and monitors the patient'sresponses to the hearing assessment signals in substantially real time;and providing visual or audiovisual communication between the patientand the clinician during the hearing test session using the computernetwork.
 11. The method of claim 10, further comprising transmittingdistortion product emission level measurements or middle ear compliancemeasurements over the computer network to the remote test administrationsite using the portable hearing test device.
 12. The method of claim 10,wherein the hearing assessment signals have harmonic distortion of tonefrequencies that meet ANSI standards.
 13. The method of claim 10,wherein the hearing assessment signals are transmitted to the patientsuch that the signals are within about 1% of an indicated tonefrequency.
 14. The method of claim 10, wherein the hearing assessmentsignals include frequency tones, narrow band noise, broadband noise,recorded noise and speech, and live speech.
 15. The method of claim 10,further comprising allowing the clinician at the remote testadministration site to monitor noise at the patient test site using anaudio analyzer on-board the portable hearing test device.